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Kvalitetssystem


Certifikater


Audit History


Revisionshistorie



  • 2016

    ·Finasteride og progesteron bestod US FDA-inspektion
    ·Progesteron bestod EU EDQM-inspektion


  • 2019

    ·Finasteride, Progesteron og Budesonid bestod US FDA-inspektion
    ·Finasteride bestod Japans PMDA-inspektion

  • 2020

    ·Cyproteronacetat bestod Australiens TGA

  • 2021

    ·Oxcarbazepin bestod P.R. China Hubei Drug Administration inspektion

  • 2023

    ·Oxcarbazepin og Dutasteride bestod MFDS-inspektionen

  • 2024

    ·Cyproteronacetat bestod EDQM-inspektion




Liste over vigtigste QC-instrumenter



Instrument Type Fabrikant
HPLC 1100 Agilent
1200 Agilent
1260 Agilent
1290 Agilent
LC-20AT Shimadzu
LC-2030C PLUS Shimadzu
Ultimativ 3000 ThermoFisher
Waters e2695 Vand
GC 6890 Agilent
7697A Agilent
7890 Agilent
GC-2030AF Shimadzu
OG Avatar 380/iS10 NICOLET
ALFA-T BRUKER
UV-Vis UV-2600/2000/1800 Shimadzu
AAS AA7000 Shimadzu
Polarimeter Autopol V/ⅠS2 Rudolph
Autopol Ⅳ-T Rudolph
Laser Mastersizer Mastersizer 3000 Malvern
HEJ-RHODS SYMPATEC
TOC OCD-VWP Shimadzu
HTY-DI1500 TAILIN
Karl-Fisher Titrator KF870/831/915 Metrohm
Potentiel titrator 905/916 Metrohm
Endotoksin detektor PKF-96 ACC
Air Jet Sieve 200LS Hosokawa alpine
pH-måler PHS-3E REX
Ledningsevnemåler DDS-307 REX
Temperatur- og fugtskab Climacell 707 MMM
Labonce-380GS Labonce
LHH-250SD BLUEPARD
CTHI-150B KONTAKT



Audit History


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